Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT06070558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-30', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-09-30', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Curve representing the difference between displacement of condyles during Temporo Mandibular Joint (TMJ) movements in healthy subjects and in subjects with known Temporo Mandibular Disorder (TMD).', 'timeFrame': 'Baseline (day 0)'}], 'secondaryOutcomes': [{'measure': 'Curve representing the displacement of the articular discs during TMJ movements', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Curve representing the difference between displacement of joint discs during TMJ movements in healthy subjects and in subjects with known TMD', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Characterization of the volume in mm3 of the main masticatory muscles during movement by MRI in healthy and pathological subjects.', 'timeFrame': 'Baseline (day 0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Temporomandibular Joint Disorders']}, 'descriptionModule': {'briefSummary': 'The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.\n\nThis sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult: age ≥ 18 years old;\n* Person with the capacity to understand the instructions given;\n* Person affiliated to a social security scheme or beneficiary of such a scheme;\n* Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.\n\nExclusion Criteria:\n\n* Person with large-scale metallic dental reconstructions;\n* Edentulism more than 5 teeth;\n* Claustrophobia;\n* Contraindication to performing an MRI examination\n* Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code'}, 'identificationModule': {'nctId': 'NCT06070558', 'acronym': 'ARTEMIS', 'briefTitle': 'ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging', 'orgStudyIdInfo': {'id': '2021-A02648-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy', 'description': 'Healthy volunteers', 'interventionNames': ['Device: MRI with Real Time MRI Rapid Flash sequence']}, {'type': 'OTHER', 'label': 'Temporomandibular Joint Disorders', 'description': 'Patients with Temporomandibular Joint Disorders', 'interventionNames': ['Device: MRI with Real Time MRI Rapid Flash sequence']}], 'interventions': [{'name': 'MRI with Real Time MRI Rapid Flash sequence', 'type': 'DEVICE', 'description': 'MRI examination of temporomandibular joint with Real Time MRI Rapid Flash sequence', 'armGroupLabels': ['Healthy', 'Temporomandibular Joint Disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Pedro Augusto GONDIM TEIXEIRA, MD, PhD', 'role': 'CONTACT', 'email': 'p.teixeira@chru-nancy.fr', 'phone': '0033 3 83 85 21 61'}, {'name': 'Gabriela Hossu, PhD', 'role': 'CONTACT', 'phone': '0033 3 83 15 50 96'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pedro TEIXEIRA-GONDIM, MD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}